- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076049
The Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF Study)
Evaluation of a Novel Solution, IrriSept, a New Delivery System, Containing a Long-acting Antimicrobial Agent for Irrigation of Skin and Soft Tissue Infections, in the Form of an Abscess in the Emergency Department: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Tampa, Florida, United States, 33606
- Tampa General Hospital - University of South Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 to 80
- Skin and soft tissue infections (SSTIs), in the form of an abscess, which will require incision and drainage.
- Patient able to provide an informed consent.
- Patient volunteers to participate.
Exclusion Criteria:
- Wound was caused by human or animal bite.
- Wound is a blunt crush injury or has tendon, bone, or joint involvement.
- Diabetic foot infection.
- Anticipated incision size less than 5mm.
- Abscess extends to the muscle layer.
- Admission to hospital for any reason, including IV antibiotics.
- Clinical signs of systemic infection on initial patient encounter.
- Prior history of allergy or hypersensitivity to CHG.
- Neutropenic (known ANC<500/mm3), HIV (known CD4<50), or other severely immunocompromised state (e.g., receiving chemotherapy).
- Patient is diagnosed with systemic lupus erythematosus or other immunological disease.
- Currently in police custody.
- Patient withdraws from participation.
- Patient unable or unwilling to give informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care (SoC)
For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s).
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The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects.
The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits.
|
Active Comparator: Irrisept
For subjects randomized to the investigational group, Irrisept was used.
|
Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound State at 48-Hour Follow-up Visit
Time Frame: 48 hours
|
The primary endpoint was overall wound progression and signs of infection 48 hours post-treatment.
This was measured via a blinded investigator's discretion and recorded as 'improved', 'no change', 'progression of signs or symptoms of infection', or 'immediate treatment required' if an infection had progressed to a certain extent.
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Performance of Irrisept to the Current SoC
Time Frame: 48 hours
|
The study tracked any instance of a subject's conditions worsening compared to their baseline measurements. This included a worsening in the size (length and width) and clinical signs (erythema, area, induration, tenderness, warm, pain, cellulitis and other) of the infection. While the protocol states the overall prevalence of Methicillin-resistant Staphylococcus Aureus (MRSA) colonization is the secondary objective, this information was not collected by the site. Therefore, worsening of clinical outcomes is considered the secondary objective. |
48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Wein, MD, Tampa General Hospital, University South Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108527
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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